MERIFLUOR Pneumocystis 222030

GUDID 00840733101106

MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens.

MERIDIAN BIOSCIENCE, INC.

Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

• Primary Device ID: 00840733101106
• NIH Device Record Key: 4e952ab4-4ef9-477f-b6ec-d3d374297d9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MERIFLUOR Pneumocystis
• Version Model Number: 222030
• Catalog Number: 222030
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101106 [Primary]

FDA Product Code

• LYF: Pneumocystis Carinii

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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